Home / 510(k) Clearances / K201867

510(k) K201867

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System by Baxter Healthcare Corporation — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2020
Date Received
July 7, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Baxter Healthcare Corporation

  • K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (December 16, 2025)
  • K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library (July 28, 2025)
  • K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (July 28, 2025)
  • K243529 — Solution Administration Sets (March 14, 2025)
  • K242339 — Intravascular Extension Sets and Accessories (February 28, 2025)
  • K242390 — Novum IQ Syringe Pump (40800BAXUS) (September 5, 2024)
  • K241564 — Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE M (August 2, 2024)
  • K211122 — Novum IQ Large Volume Pump (March 29, 2024)
  • K230665 — Dose IQ Safety Software (March 29, 2024)
  • K232467 — CleanCart A, CleanCart C, AK 98 Hemodialysis Machine (September 14, 2023)

Other clearances for product code FKX

  • K250523 — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes S (October 2, 2025)
  • K243371 — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 (May 16, 2025)
  • K220935 — Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supe (December 29, 2022)
  • K222318 — Fresenius Liberty Select Cycler (October 31, 2022)
  • K212522 — Lilliput APD System (April 15, 2022)
  • K212658 — CloudCath Peritoneal Dialysis Drain Set Monitoring System (February 9, 2022)
  • K181108 — Fresenius Liberty Select Cycler (May 24, 2018)
  • K173718 — Liberty Cycler Set (May 1, 2018)
  • K171652 — Fresenius Liberty Select Cycler (September 15, 2017)
  • K151525 — Amia Automated PD System with Sharesource (October 9, 2015)